Erectile DysfunctionNCT03699943
Autologous Bone Marrow Concentrate in Treatment of Erectile Dysfunction.
A study testing CaverStem in people with Erectile Dysfunction, run by Creative Medical Health, Inc. at 1 site in United States.
Trial summary
This study assessed the safety and efficacy of autologous bone marrow concentrate and injected intra-cavernously into patients with erectile dysfunction (ED). Specifically, this study will evaluate ED treatment >18 year old men, a demographic where the etiology of ED is attributable primarily to the loss of corporal… Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- CaverStem
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2015to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic organic ED duration at least 0.5 years
- Diagnosis of ED based on Doppler Ultrasound and/or dynamic infusion cavernosonometry.
- Baseline International Index of Erectile Function (IIEF-5) score of < 21
- Oral medications and intracavernous pharmacological approaches have been deemed ineffective, contraindicated or cannot be tolerated.
- Concurrently undergoing treatment with testosterone.
- Willing to forego any other treatments for ED over the course of the study.
Who cannot join
- Subjects using any medications/drugs with known effects on erectile function within 4 weeks of the study period, including certain antidepressants, antihistamines, diuretics, and beta-blockers.
- Subjects using herbal remedies for addressing erectile dysfunction within one month of study initiation.
- Subjects with penile prosthesis or other urinary prosthesis.
- Subjects with penile anatomical deformities (e.g. Peyronie's disease) or history of priapism.
- Previous penile surgeries for erectile dysfunction, premature ejaculation or penile enlargement.
- Diagnosis of psychogenic ED as determined by nocturnal tumenscence testing.
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- Presenting with uncontrolled or severe disease, including cardiovascular disease, diabetes, liver disease.
- Uncontrolled hypertension or hypotension (systolic blood pressure > 170 or < 90 mm Hg, and diastolic blood pressure > 100 or < 50 mm Hg)
- Suffered a cardiovascular event within 6 months prior to study initiation.
- Current or previous malignancy other than non-melanoma skin cancer (successfully treated or treatable by curative excision or other local curative therapy).
- Diagnosis of a systemic autoimmune disorder.
- Receiving immunosuppressant medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harbor - UCLA Medical Center
Torrance, California, 90502
About this study
Official title: Feasibility Study of Intra-cavernosal Administration of Non-Expanded Autologous Bone Marrow Concentrate in Treatment of Erectile Dysfunction.
This study assessed the safety and efficacy of autologous bone marrow concentrate and injected intra-cavernously into patients with erectile dysfunction (ED). Specifically, this study will evaluate ED treatment >18 year old men, a demographic where the etiology of ED is attributable primarily to the loss of corporal smooth muscle in the penis. Study endpoints will evaluate the safety and efficacy of intracavernosal bone marrow concentrate administration for treating ED patients.
Read the detailed description
Erectile dysfunction (ED) is characterized by abnormalities of the vascular system; most commonly, venous leakage (or veno-occlusive dysfunction) resulting from loss of integrity of the surrounding corporal smooth muscle. In the penile vascular system, the corporal smooth muscle is responsible for trapping the blood delivered to the corpora cavernosa via the arterial system.
Bone marrow is enriched for cells with regenerative potential, including mesenchymal stem cells, which accelerate healing of damaged tissue. The possibility of using bone marrow cells in the treatment of ED is enticing since stem/progenitor cell populations are known to secrete various growth factors, possess anti-inflammatory activities, and can differentiate into cells of the penile architecture.
This study will evaluate safety and efficacy of autologous bone marrow concentrate generated by a closed system device and injected intra-cavernously in 40 patients aged > 18 years of age diagnosed with erectile dysfunction with low dose 30 cc (20 patients) or high dose 60 cc (20 patients). Safety and efficacy will be evaluated at baseline (prior to treatment) and at 1,3,6 and 12-month follow up visits. The study will determine whether injection of bone marrow cells intra-cavernously is a clinically feasible, safe and reproducible approach for treating erectile dysfunction. A clinical registry will also be enrolling treating the same patient population (100 patients (20 cc)).
- Conditions
- Erectile Dysfunction
- Being tested
- CaverStem
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaverStemProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| CaverStem 1.0 - Low | Active comparator | Intra-cavernosal injection of autologous bone marrow concentrate for the treatment of Erectile Dysfunction. low dose 30 cc Receives: Procedure: CaverStem |
| CaverStem 1.0 - High | Active comparator | Intra-cavernosal injection of autologous bone marrow concentrate for the treatment of Erectile Dysfunction. high dose 60 cc Receives: Procedure: CaverStem |
| Caverstem 2.0 - Clinical Registry | Active comparator | Intra-cavernosal injection of autologous bone marrow concentrate for the treatment of Erectile Dysfunction. 20 cc Receives: Procedure: CaverStem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in erectile function as measured by total score in the International Index of Erectile Function
IIEF-5 scale
Measured: 6 months
Rate of Adverse Events
bruising, infection, pain
Measured: 6 months
Secondary outcomes (1)
Change in Doppler Measurements
ml/s
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start8 Dec 2015
- Primary completion31 Aug 2018
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Caverstem 1.0 - Low dose - 30 cc - 20 patients Caverstem 1.0 - High dose - 60 cc - 20 patients Caverstem 2.0 - 20 cc - 100 patients
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creative Medical Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex Gershman, Study chair, UCLA/CedarJacob Rajfer, Study director, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699943
- Sponsor's protocol ID
- 21511-01
- Status last verified
- Sep 2019
- First submitted
- 12 Dec 2015
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared among other investigators through secure clinical registry.
Publications
Bieri M, Said E, Antonini G, Dickerson D, Tuma J, Bartlett CE, Patel AN, Gershman A. Phase I and registry study of autologous bone marrow concentrate evaluated in PDE5 inhibitor refractory erectile dysfunction. J Transl Med. 2020 Jan 14;18(1):24. doi: 10.1186/s12967-019-02195-w.
PubMed 31937310
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Intra-cavernosal Administration of Non-Expanded Autologous Bone Marrow Concentrate in Treatment of Erectile Dysfunction.
- ClinicalTrials.gov ID
- NCT03699943
- Acronym / sponsor ID
- 21511-01
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Creative Medical Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2015 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assessed the safety and efficacy of autologous bone marrow concentrate and injected intra-cavernously into patients with erectile dysfunction (ED). Specifically, this study will evaluate ED treatment >18 year old men, a demographic where the etiology of ED is attributable primarily to the loss of corporal smooth muscle in the penis. Study endpoints will evaluate the safety and efficacy of intracavernosal bone marrow concentrate administration for treating ED patients.
Detailed description
Erectile dysfunction (ED) is characterized by abnormalities of the vascular system; most commonly, venous leakage (or veno-occlusive dysfunction) resulting from loss of integrity of the surrounding corporal smooth muscle. In the penile vascular system, the corporal smooth muscle is responsible for trapping the blood delivered to the corpora cavernosa via the arterial system.
Bone marrow is enriched for cells with regenerative potential, including mesenchymal stem cells, which accelerate healing of damaged tissue. The possibility of using bone marrow cells in the treatment of ED is enticing since stem/progenitor cell populations are known to secrete various growth factors, possess anti-inflammatory activities, and can differentiate into cells of the penile architecture.
This study will evaluate safety and efficacy of autologous bone marrow concentrate generated by a closed system device and injected intra-cavernously in 40 patients aged > 18 years of age diagnosed with erectile dysfunction with low dose 30 cc (20 patients) or high dose 60 cc (20 patients). Safety and efficacy will be evaluated at baseline (prior to treatment) and at 1,3,6 and 12-month follow up visits. The study will determine whether injection of bone marrow cells intra-cavernously is a clinically feasible, safe and reproducible approach for treating erectile dysfunction. A clinical registry will also be enrolling treating the same patient population (100 patients (20 cc)).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Caverstem 1.0 - Low dose - 30 cc - 20 patients Caverstem 1.0 - High dose - 60 cc - 20 patients Caverstem 2.0 - 20 cc - 100 patients
| Arm | Type | Receives |
|---|---|---|
| CaverStem 1.0 - Low | Active comparator | Procedure: CaverStemIntra-cavernosal injection of autologous bone marrow concentrate for the treatment of Erectile Dysfunction. low dose 30 cc |
| CaverStem 1.0 - High | Active comparator | Procedure: CaverStemIntra-cavernosal injection of autologous bone marrow concentrate for the treatment of Erectile Dysfunction. high dose 60 cc |
| Caverstem 2.0 - Clinical Registry | Active comparator | Procedure: CaverStemIntra-cavernosal injection of autologous bone marrow concentrate for the treatment of Erectile Dysfunction. 20 cc |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic organic ED duration at least 0.5 years
- Diagnosis of ED based on Doppler Ultrasound and/or dynamic infusion cavernosonometry.
- Baseline International Index of Erectile Function (IIEF-5) score of < 21
- Oral medications and intracavernous pharmacological approaches have been deemed ineffective, contraindicated or cannot be tolerated.
- Concurrently undergoing treatment with testosterone.
Key exclusion criteria (12 listed)
- Subjects using any medications/drugs with known effects on erectile function within 4 weeks of the study period, including certain antidepressants, antihistamines, diuretics, and beta-blockers.
- Subjects using herbal remedies for addressing erectile dysfunction within one month of study initiation.
- Subjects with penile prosthesis or other urinary prosthesis.
- Subjects with penile anatomical deformities (e.g. Peyronie's disease) or history of priapism.
- Previous penile surgeries for erectile dysfunction, premature ejaculation or penile enlargement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaverStem | Procedure or surgery | CaverStem 1.0 - High, CaverStem 1.0 - Low, Caverstem 2.0 - Clinical Registry |
Primary outcome
Improvement in erectile function as measured by total score in the International Index of Erectile Function
Time frame: 6 months
IIEF-5 scale
Rate of Adverse Events
Time frame: 6 months
bruising, infection, pain
1 secondary outcome
Change in Doppler Measurements
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Derived from this study: PubMed 31937310Bieri M, Said E, Antonini G, Dickerson D, Tuma J, Bartlett CE, Patel AN, Gershman A. Phase I and registry study of autologous bone marrow concentrate evaluated in PDE5 inhibitor refractory erectile dysfunction. J Transl Med. 2020 Jan 14;18(1):24. doi: 10.1186/s12967-019-02195-w.
- Individual participant dataSharing planned: Yes. Data will be shared among other investigators through secure clinical registry.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Gershman study chair
UCLA/Cedar
Jacob Rajfer study director
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CaverStem in people with Erectile Dysfunction, run by Creative Medical Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in erectile function as measured by total score in the International Index of Erectile Function (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03699943, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.